Application 208249
- Type
- ANDA
- Sponsor
- CSPC OUYI
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AZITHROMYCIN | AZITHROMYCIN | TABLET;ORAL | EQ 500MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A208249-001 | AZITHROMYCIN | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A208249-001 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A208249-001 | AZITHROMYCIN | EQ 500MG BASE | TABLET / ORAL | AB | 2018-10-25 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A208249-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208249-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A208249-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208249-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208249-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208249-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208249-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208249-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208249-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A208249-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208249-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208249-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208249-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A208249-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208249-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A208249-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A208249-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A208249-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A208249-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A208249-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208249-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A208249-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A208249-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A208249-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A208249-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A208249-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A208249-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208249-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A208249-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A208249-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A208249-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A208249-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A208249-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A208249-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A208249-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A208249-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A208249-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A208249-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A208249-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A208249-001 | AB | 1 | cb3db0bc1861… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Azithromycin Dihydrate | AZITHROMYCIN DIHYDRATE | NuCare Pharmaceuticals,Inc. | 21c67de0-3a4e-caab-e063-6394a90ae3cd | 2026-07-30 | Warnings, Adverse reactions | 208249 ANDA208249 |
| Azithromycin Dihydrate | AZITHROMYCIN DIHYDRATE | PD-Rx Pharmaceuticals, Inc. | 0c926669-62b2-4ad3-8289-173c5818a9c1 | 2026-07-29 | Warnings, Adverse reactions | 208249 ANDA208249 |
| Azithromycin Dihydrate | AZITHROMYCIN DIHYDRATE | Bryant Ranch Prepack | 7d78cd8e-0c63-46d6-b018-939fcbbe42a6 | 2026-06-24 | Warnings, Adverse reactions | 208249 ANDA208249 |
| Azithromycin Dihydrate | AZITHROMYCIN DIHYDRATE | REMEDYREPACK INC. | 7711e846-0bb3-486c-8511-f445e264cd98 | 2026-06-12 | Warnings, Adverse reactions | 208249 ANDA208249 |
| Azithromycin Dihydrate | AZITHROMYCIN DIHYDRATE | Precision Dose, Inc. | 3962bc34-8236-4ac1-8ffd-2edbd430c3eb | 2026-04-08 | Warnings, Adverse reactions | 208249 ANDA208249 |
| Azithromycin Dihydrate | AZITHROMYCIN DIHYDRATE | REMEDYREPACK INC. | c7ed6985-1d1d-48af-9df8-64b12821789e | 2026-04-06 | Warnings, Adverse reactions | 208249 ANDA208249 70518-3168 |
| AZITHROMYCIN DIHYDRATE | AZITHROMYCIN DIHYDRATE | DIRECT RX | a6426d5f-5518-3c69-e053-2995a90af50f | 2026-03-17 | Warnings, Adverse reactions | 208249 ANDA208249 72189-090 |
| Azithromycin Dihydrate | AZITHROMYCIN DIHYDRATE | A-S Medication Solutions | de5b0c2b-9a7d-46e9-8169-4100442efa9b | 2026-03-03 | Warnings, Adverse reactions | 208249 ANDA208249 |
| Azithromycin Dihydrate | AZITHROMYCIN DIHYDRATE | Sportpharm LLC | 11446677-a3dc-40cb-897d-7a9851b8c89c | 2026-02-06 | Warnings, Adverse reactions | 208249 ANDA208249 |
| Azithromycin Dihydrate | AZITHROMYCIN DIHYDRATE | Preferred Pharmaceuticals Inc. | 3b90572c-cc24-49f0-baaf-09022a2f9a00 | 2026-01-21 | Warnings, Adverse reactions | 208249 ANDA208249 |
| Azithromycin Dihydrate | AZITHROMYCIN DIHYDRATE | AvPAK | b635019e-7fd4-7f9e-e053-2a95a90a388c | 2026-01-08 | Warnings, Adverse reactions | 50268-076 |
| Azithromycin Dihydrate | AZITHROMYCIN DIHYDRATE | Health Department, Oklahoma State | 4747c5d8-4831-c725-e063-6394a90a4fda | 2025-12-31 | Warnings, Adverse reactions | 208249 ANDA208249 |
| Azithromycin Dihydrate | AZITHROMYCIN DIHYDRATE | Redpharm Drug | 2fd1f4b5-6c32-3075-e063-6294a90a0d4b | 2025-12-27 | Warnings, Adverse reactions | 208249 ANDA208249 |
| Azithromycin Dihydrate | AZITHROMYCIN DIHYDRATE | Coupler LLC | 4196e616-bdd8-9e88-e063-6394a90ac81d | 2025-10-20 | Warnings, Adverse reactions | 208249 ANDA208249 |
| Azithromycin Dihydrate | AZITHROMYCIN DIHYDRATE | TAGI Pharma, Inc. | 41e2163b-af61-4323-8b9c-2d44fc122fd9 | 2025-03-05 | Warnings, Adverse reactions | 208249 ANDA208249 51224-122 |
| Azithromycin Dihydrate | AZITHROMYCIN DIHYDRATE | Advanced Rx of Tennessee, LLC | f1755cf3-bf7f-be40-e053-2a95a90a8536 | 2024-12-31 | Warnings, Adverse reactions | 208249 ANDA208249 80425-0220 |
| Azithromycin Dihydrate | AZITHROMYCIN DIHYDRATE | Proficient Rx LP | bb97a057-2537-41ae-b50c-a80605039c30 | 2024-11-01 | Warnings, Adverse reactions | 208249 ANDA208249 71205-491 |
| Azithromycin Dihydrate | AZITHROMYCIN DIHYDRATE | A-S Medication Solutions | fcf098d5-dfd5-4a0d-81f7-6afa1a203a27 | 2024-10-15 | Warnings, Adverse reactions | 208249 ANDA208249 |
| Azithromycin Dihydrate | AZITHROMYCIN DIHYDRATE | A-S Medication Solutions | b4c05e22-4a54-4948-abf8-8a479d465d30 | 2024-10-15 | Warnings, Adverse reactions | 208249 ANDA208249 |
| Azithromycin Dihydrate | AZITHROMYCIN DIHYDRATE | Proficient Rx LP | edecf20d-c681-418b-9c47-02fb32d2b3c0 | 2024-09-01 | Warnings, Adverse reactions | 208249 ANDA208249 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-4528 | Azithromycin Dihydrate | Azithromycin Dihydrate | A-S Medication Solutions | ANDA | Current |
| 50090-4528 | Azithromycin Dihydrate | Azithromycin Dihydrate | A-S Medication Solutions | ANDA | Current |
| 50090-4528 | Azithromycin Dihydrate | Azithromycin Dihydrate | A-S Medication Solutions | ANDA | Current |
| 50090-4606 | Azithromycin Dihydrate | Azithromycin Dihydrate | A-S Medication Solutions | ANDA | Current |
| 50090-4606 | Azithromycin Dihydrate | Azithromycin Dihydrate | A-S Medication Solutions | ANDA | Current |
| 50090-4606 | Azithromycin Dihydrate | Azithromycin Dihydrate | A-S Medication Solutions | ANDA | Current |
| 50090-4700 | Azithromycin Dihydrate | Azithromycin Dihydrate | A-S Medication Solutions | ANDA | Current |
| 50090-4700 | Azithromycin Dihydrate | Azithromycin Dihydrate | A-S Medication Solutions | ANDA | Current |
| 50268-076 | Azithromycin Dihydrate | Azithromycin Dihydrate | AvPAK | ANDA | Current |
| 50268-076 | Azithromycin Dihydrate | Azithromycin Dihydrate | AvPAK | ANDA | Current |
| 50268-076 | Azithromycin Dihydrate | Azithromycin Dihydrate | AvPAK | ANDA | Current |
| 51224-122 | Azithromycin Dihydrate | Azithromycin Dihydrate | TAGI Pharma, Inc. | ANDA | Current |
| 51224-122 | Azithromycin Dihydrate | Azithromycin Dihydrate | TAGI Pharma, Inc. | ANDA | Current |
| 53002-0474 | Azithromycin Dihydrate | Azithromycin Dihydrate | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-7221 | Azithromycin Dihydrate | Azithromycin Dihydrate | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55700-896 | Azithromycin Dihydrate | Azithromycin Dihydrate | Quality Care Products, LLC | ANDA | Current |
| 68071-2775 | Azithromycin Dihydrate | Azithromycin Dihydrate | NuCare Pharmceuticals,Inc. | ANDA | Current |
| 68071-2775 | Azithromycin Dihydrate | Azithromycin Dihydrate | NuCare Pharmceuticals,Inc. | ANDA | Current |
| 68788-8311 | Azithromycin Dihydrate | Azithromycin Dihydrate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-3168 | Azithromycin Dihydrate | Azithromycin Dihydrate | REMEDYREPACK INC. | ANDA | Current |
| 70518-3168 | Azithromycin Dihydrate | Azithromycin Dihydrate | REMEDYREPACK INC. | ANDA | Current |
| 70518-3168 | Azithromycin Dihydrate | Azithromycin Dihydrate | REMEDYREPACK INC. | ANDA | Current |
| 71205-491 | Azithromycin Dihydrate | Azithromycin Dihydrate | Proficient Rx LP | ANDA | Current |
| 72189-090 | AZITHROMYCIN DIHYDRATE | AZITHROMYCIN DIHYDRATE | DIRECT RX | ANDA | Current |
| 72189-090 | AZITHROMYCIN DIHYDRATE | AZITHROMYCIN DIHYDRATE | DIRECT RX | ANDA | Current |
| 72789-063 | Azithromycin Dihydrate | Azithromycin Dihydrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-063 | Azithromycin Dihydrate | Azithromycin Dihydrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-063 | Azithromycin Dihydrate | Azithromycin Dihydrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-066 | Azithromycin Dihydrate | Azithromycin Dihydrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-066 | Azithromycin Dihydrate | Azithromycin Dihydrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-066 | Azithromycin Dihydrate | Azithromycin Dihydrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-066 | Azithromycin Dihydrate | Azithromycin Dihydrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-066 | Azithromycin Dihydrate | Azithromycin Dihydrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-066 | Azithromycin Dihydrate | Azithromycin Dihydrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-066 | Azithromycin Dihydrate | Azithromycin Dihydrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-169 | Azithromycin Dihydrate | Azithromycin Dihydrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-169 | Azithromycin Dihydrate | Azithromycin Dihydrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-169 | Azithromycin Dihydrate | Azithromycin Dihydrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 80425-0220 | Azithromycin Dihydrate | Azithromycin Dihydrate | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |